8D Report DISTRIBUTED TO ALL TEAM MEMBERS Spec No / Part No: CHECK, SIGN, AND DATE BELOW SHOWING APPROVAL ON STATUS OF 8D PLEASE FAX BACK TO ME WITHIN DAYS OF RECEIPT CORRECTIVE ACTION: ACCEPTED SOME QUESTIONS REMAIN FOR CLARIFICATION NOT ACCEPTED – PLEASE EXPLAIN SIGNED: DATE: Please return to the Attention of _ via fax at (?)?? - Thank you! FM 341.12/08-05-02 (Replacing FM341.11/06-07-01) Page PROBLEM SOLVING WORKBOOK Disciplined Problem Solving Note; See instruction book for guidance at each discipline THE DISCIPLINED PROBLEM SOLVING PROCESS SUMMARY REPORT Quality Title: Date Opened: Last Updated Product/Process Information: Organization Information: Ref No.: D0 Emergency Response Action(s): % Effective: Date Implemented: Verification/Validation: Customer Contact: D1 Team (Name, Dept., Tel) Champion: D2 Problem Problem Statement: D3 Interim Containment Action(s): % Effective: D0 Symptom(s): Date Implemented: D4 Root Cause(s) and Escape Point(s) % Contribution: D5 Chosen Permanent Corrective Action(s) % Effective: D6 Implemented Permanent Corrective Action(s): Validation: Date Implemented: D7 Prevent Actions: Date Implemented: D7 Systemic Prevent Recommendations: Responsibility: D8 Team and Individual Recognition: Date Closed: Page FM 341.12/08-05-02 (Replacing FM341.11/06-07-01) Reported by: THE DISCIPLINED PROBLEM SOLVING PROCESS Use this process flow to guide you through the disciplined problem solving process Also refer to the Instruction Book for further guidance If you need any further advice or help seek out someone in the Quality Assurance Department who has been trained to a more detailed level of problem solving D0 Consider emergency response action (ERA); decision to use, and preparation for, this or the more detailed approach,  D1 Establish the team and use teamworking approach, if required  Describe the problem  Develop, validate and implement the interim containment action (ICA), if required  Find, define and verify root cause(s) and escape point(s)  Choose and verify permanent corrective actions (PCAs) for root cause and escape point  Implement and validate permanent corrective actions (PCAs)  Prevent recurrence of this and possible similar failures, also identify systematic improvement opportunities  Recognise team and individual contributions, as appropriate D2 D3 D4 D5 D6 D7 D8 DISCIPLINE D0 You are aware that something has gone wrong, and you don’t know the reason why Before you can describe the problem accurately and thus find root cause(s), you may need to protect the customer (internal or external) from continuing to experience the symptom, if this has not already been done  What was the Emergency Response action(s): All inventory was accounted for Lot “1” remaining samples put in quarantine Possible Actions What did we actually (results!) (Use the following as a check list)           WIP on hold WIP checked Warehouse stock on hold Warehouse stock checked Deliveries in transit identified Deliveries in transit checked Deliveries at customer checked Verify control plan controls are properly working Review all past inspection data Other actions Note: See Instruction book for guidance at each Discipline Page FM 341.12/08-05-02 (Replacing FM341.11/06-07-01) TIME LINE OF EVENTS As you proceed through the Disciplines, you will find out information concerning the product and process associated with the problem Document any information such as date of approval of first batches made and any changes to process, material, methods, machines, people or the environment with dates Keep this Time Line live through the investigation Dates Event(s) i.e changes or happenings DISCIPLINE PROBLEM STATEMENT Define very simply “What is wrong with what” i.e what object has what defect? Use the techniques of “Sub Dividing” and “Stair Stepping” to assist you, to show the relationship of the Problem Statement to the symptom Note: See Instruction Book for guidance at each discipline Page FM 341.12/08-05-02 (Replacing FM341.11/06-07-01) DISCIPLINE DESCRIBE THE PROBLEM Before trying to define the root cause or jump to solutions – stop and take time to describe the problem, using as much data and facts as you can gather Use the questions below to guide you and, if it helps, draw a diagram on the next page It is possible that the problem was not described correctly on the complaint/DMR you received If so re-state the problem correctly PROBLEM PROFILE DESCRIPTION DATA Be as specific as possible, identifying part numbers, machines, dates, quantities etc DESCRIPTION AREA QUESTIONS CHECKLIST WHAT Object? What object has the defect? Defect? What is the defect? WHERE Seen on object? Where specifically on the object you see the defect? Seen geographically? Where geographically is defective object observed? the WHEN First seen?  By the customer?  When did we make the part? When in time, was the defect first observed? When seen since? When, since the first observation, has the defect been observed? (e.g continuously, in patterns, only on Mondays?) When seen in When is the defect seen in the process of making the object? When were the defectives made?   Process flow? Operating cycle? When is the defect seen in the operating cycle of the object? (i.e when the object/system is used)  Life cycle? When is the defect seen in the life of the object? (e.g when new or after 200 hours?) HOW BIG How many objects have the defect? How many objects have the defect? How many/much defect(s) per object? How much or how many defect(s) per object? (ie are all bad parts defective to the same extent?) What is the trend? How has the trend developed since first observation and what is it now? (e.g stable/erratic, getting better/worse) Consider Similar Parts Could this problem affect other similar parts: on other lines, in other plants with the same process, other parts with the same materials/process? List those areas or parts you consider at risk, and inform the Champion to enable communication with others Similar parts Page FM 341.12/08-05-02 (Replacing FM341.11/06-07-01) D2 Attach a Picture or Diagram here D2 continued Attach any other relevant documents to this workbook as you go DISCIPLINE INTERIM CONTAINMENT ACTION (ICA) Now that you have completed D2, review the emergency response action to see if it can be used as an ICA or improved in order to allow production to continue while still detecting and containing all defective output, giving you time to analyse root cause If it can’t, then identify a better containment action (Do not remove Interim Corrective Action until permanent corrective action is implemented and verified) Note:    In some circumstances an ICA may not be needed IS AN IS ICA REQUIRED? ERA OK AS AN ICA? IF YOU CONSIDER ICA NOT NECESSARY, WHY NOT? ICA NOT NECESSARYCONTAINMENT ACTION IS PERMENANT     DESCRIBE THE ICA THAT YOU PROPOSE – WHO WILL DO IT, AND WHEN? – HOW WILL OK PARTS BE IDENTIFIED? – IF YOU PROPOSE CHANGE(S), REPORT TO CHAMPION AND OBTAIN APPROVAL OF CONTROL PLAN, WORK INSTRUCTIONS AND AUDIT SHEETS Keep the following chart up to date until you complete D8 EFFECT OF ACTIONS ON CUSTOMER ACTION DATE IN PLACE MONTH ERA ICA PCA Page FM 341.12/08-05-02 (Replacing FM341.11/06-07-01) 10 11 12 D4 continued ROOT CAUSE THEORIES Consider the Cause of Effect Diagram Then create some Root Cause Theories that explain a strong logical link to the Problem Statement and Problem Profile recorded at D2 Document your theories as complete sentence statements ROOT CAUSE THEORY STATEMENTS: REF STATEMENT LOGIC TEST D4 continued Consider each theory in turn Eliminate those which are not logical when you consider the Time Line of Events and/or the Problem Profile Record your reasons for elimination THEORY REF REASON(S) FOR ELIMINATION ESCAPE POINT D4 continued  DO WE HAVE AN INSPECTION/CONTROL POINT THAT SHOULD HAVE ENSURED THAT NON-CONFORMANCES WERE FOUND? YES OR NO?  IF YES, WHY DID THE INSPECTED/CONTROL POINT FAIL? Page D4 continued STAIR STEP LOGIC For the theories which pass through the Logic Test, show the logical links (steps) between the root cause theory, the problem statement and the symptom Do this for each theory Repeatedly ask why? to show the links FM 341.12/08-05-02 (Replacing FM341.11/06-07-01) ROOT CAUSE THEORY NUMBER ROOT CAUSE THEORY NUMBER WHY? WHY? WHY? WHY? WHY? PROVING THE ROOT CAUSE – VERIFICATION ACTION PLAN What testing are you going to to prove that this is (or these could be) the root cause? Ref Task Who When Outcome? UPGRADING THE PROBLEM If you find after these tests that you have not been able to discover cause(s), then take this workbook to your Champion so that the Champion can get you specialist advice Page 10 DISCIPLINE CHOOSE PERMANENT CORRECTIVE ACTIONS FM 341.12/08-05-02 (Replacing FM341.11/06-07-01) WHAT ARE YOUR IDEAS FOR PERMANENT CORRECTIVE ACTIONS? (This is one of the most important steps in effective problem solving At this step it is imperative that appropriate time is alloted to thoroughly prove out the proposed solution(s) It should be verified on multiple machines, across all production shifts, etc A rush to conclusion here can lead to ineffective corrective action and recurrence of the problem) -  CHOSEN PCA  VERIFICATION - How you know (proof) that it will work?  APPROVAL - Take the workbook to your Champion for the PCA to be reviewed and proposal(s) approved DISCIPLINE IMPLEMENT PERMANENT CORRECTIVE ACTIONS  Define the precise actions you will need to take to implement and validate effectiveness of the PCA (use Key Tasks Action Plan and Monitor.)  List which documents will need to be formally changed, as a result of these actions DISCIPLINE PREVENT ACTIONS Take a moment to look back at this problem Why did it happen in the first place? What lessons can be learnt? What changes need to be made to ensure that this and similar problems never happen again? Also note down some specific improvements that need to be made in areas such as systems, procedures, machinery, maintenance, people and training Prevent Actions Notes: Systems etc Prevent Recommendations Notes: Page 11 FM 341.12/08-05-02 (Replacing FM341.11/06-07-01) DISCIPLINE CONGRATULATE THE TEAM (& COMPLETE THE TASK) Make sure that you have completed this workbook, presented it to your Champion to enable communication with others Express thanks to those who have helped you in dealing with this problem FINALLY – Thank YOU for all your diligent work KEY TASKS ACTION PLAN AND MONITOR Use this page, as you move through the workbook to make note of actions that you (or others you have asked) have identified Use the ‘complete’ section to monitor progress of the tasks Ref Task Who Page 12 FM 341.12/08-05-02 (Replacing FM341.11/06-07-01) When % Complete 25 50 75 100 DISCIPLINE DEFINE & VERIFY ROOT CAUSE Brainstorm all possible causes of the problem and record them using the area headings to guide you List all your ideas and not criticise any at this stage After your first attempt, take time to think and add any other possible cause(s) METHODS/PROCESSES EQUIPMENT CAUSE AND EFFECT DIAGRAM PROBLEM STATEMENT (See D2) ENVIRONMENT PEOPLE Note: MATERIALS If you need any further advice or help, seek out someone in the Quality Assurance Department who has been trained to a more detailed level of problem solving FM 341.12/08-05-02 (Replacing FM341.11/06-07-01) Page Page ...Page PROBLEM SOLVING WORKBOOK Disciplined Problem Solving Note; See instruction book for guidance at each discipline THE DISCIPLINED PROBLEM SOLVING PROCESS SUMMARY REPORT... (Replacing FM341.11/06-07-01) Reported by: THE DISCIPLINED PROBLEM SOLVING PROCESS Use this process flow to guide you through the disciplined problem solving process Also refer to the Instruction Book... Implemented: Verification/Validation: Customer Contact: D1 Team (Name, Dept., Tel) Champion: D2 Problem Problem Statement: D3 Interim Containment Action(s): % Effective: D0 Symptom(s): Date Implemented: